中药质量标志物(Q-Marker)研究进展及对中药质量研究的思考  

Research progress on Q-Marker of traditional Chinese medicine and thoughts on quality research of Chinese materia medica

作　　者：阳长明 杨平 刘乐环 周思源 YANG Chang-ming;YANG Ping;LIU Le-huan;ZHOU Si-yuan(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100022

出　　处：《中草药》2021年第9期2519-2526,共8页Chinese Traditional and Herbal Drugs

摘　　要：梳理了中药质量标志物(quality marker,Q-Marker)在药材、饮片、制剂质量研究及全过程研究中的应用进展,中药Q-Marker的提出为中药质量研究和全过程控制提供了研究思路,并具有很好的指导意义。提出应加强与有效性和安全性相关联的质量研究,加强整体质量表征和多元化控制,完善源头和全过程质量控制,重视药材、饮片和制剂之间的相关性研究,分阶段开展质量标准研究,不断提高中药质量控制水平。The application of quality markers(Q-Marker)of traditional Chinese medicine(TCM)in the whole process of quality control research of medicinal materials,herbal pieces and preparations are reviewed in this paper,and the Q-Marker of TCM provide a good guiding significance and research idea for the quality research and whole process control of TCM.It is proposed that the quality research of TCM should strengthen the association with effectiveness and safety,strengthen the holistic quality representation and diversified quality control methods,improve the quality control of the source and whole process,and pay more attention to the correlation research among the medicinal materials,pieces and preparations.The quality standards of TCM can be carried out in different stages,so as to improve the quality control level of TCM.

关 键 词：质量标志物 药材质量 饮片质量 制剂质量 中药质量 相关性 全过程质量控制 

分 类 号：R283[医药卫生—中药学] R284[医药卫生—中医学]